{"type":"trials","record":{"id":41434,"source_id":"clinicaltrials-gov","external_id":"NCT05407636","title":"Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD","brief_summary":"ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.","overall_status":"Active Not Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"AbbVie","enrollment":735,"countries":["United States","Canada","France","Germany","Hungary","Italy","Japan","Puerto Rico","Spain","United Kingdom"],"start_date":"2022-01-13","completion_date":"2027-11-01","last_update_date":"2026-08-03","source_url":"https://clinicaltrials.gov/study/NCT05407636","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"ASCENT","age_range":"50 Years to 89 Years","comparator":"Control Arm","organization":"AbbVie","interventions":["ABBV-RGX-314 Dose 1","ABBV-RGX-314 Dose 2","Aflibercept (EYLEA®)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean change from baseline in Best Corrected Visual Acuity (BCVA) — At Week 54","Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs — Week 50","Incidences of ocular and overall AEs — Through Week 54","Proportion of participants with improved BCVA — Week 54","Proportion of participants with worsened BCVA — Week 54","Proportion of participants (1) gaining or losing greater than 0 letters; (2) maintaining vision compared with baseline…","Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injection (ABBV-RGX- 3…","Mean change from Week 54 to Week 108 in BCVA (control arm participants who cross over to ABBV-RGX-314) — Week 54 to Wee…","Mean change in central retinal thickness (CRT) as measured by SD-OCT — Through Week 108","Mean change in central point thickness (CPT) as measured by SD-OCT — Through Week 108","Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) a…","Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized partici…","Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized part…","Proportion of participants that received 1 or 2 injections through Week 54 (ABBV-RGX-314 randomized participants) and f…","Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 compared wi…","Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 compared wi…","Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 ran…","Supplemental anti-VEGF injection annualized rate through Week 54 (ABBV-RGX-314 randomized participants) — Through Week…","Percent reduction in anti-VEGF injection annualized rate after Week 58 through Week 108 relative to the year prior to s…","Supplemental anti-VEGF injection annualized rate after Week 58 through Week 108 (control arm participants who cross ove…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["AMD","nAMD","Wet Age-related Macular Degeneration","wAMD","WetAMD","CNV","ABBV-RGX-314 Dose 1","ABBV-RGX-314 Dose 2","Aflibercept (EYLEA®)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct05407636","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-01-13 to 2027-11-01","comparator":"Control Arm","confidence":"structured-source","population":"ALL · 50 Years to 89 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.812Z","intervention":["ABBV-RGX-314 Dose 1","ABBV-RGX-314 Dose 2","Aflibercept (EYLEA®)"],"participants":735,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Mean change from baseline in Best Corrected Visual Acuity (BCVA) — At Week 54","Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs — Week 50","Incidences of ocular and overall AEs — Through Week 54","Proportion of participants with improved BCVA — Week 54","Proportion of participants with worsened BCVA — Week 54","Proportion of participants (1) gaining or losing greater than 0 letters; (2) maintaining vision compared with baseline…","Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injection (ABBV-RGX- 3…","Mean change from Week 54 to Week 108 in BCVA (control arm participants who cross over to ABBV-RGX-314) — Week 54 to Wee…","Mean change in central retinal thickness (CRT) as measured by SD-OCT — Through Week 108","Mean change in central point thickness (CPT) as measured by SD-OCT — Through Week 108","Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) a…","Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized partici…","Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized part…","Proportion of participants that received 1 or 2 injections through Week 54 (ABBV-RGX-314 randomized participants) and f…","Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 compared wi…","Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 compared wi…","Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 ran…","Supplemental anti-VEGF injection annualized rate through Week 54 (ABBV-RGX-314 randomized participants) — Through Week…","Percent reduction in anti-VEGF injection annualized rate after Week 58 through Week 108 relative to the year prior to s…","Supplemental anti-VEGF injection annualized rate after Week 58 through Week 108 (control arm participants who cross ove…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41434","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}